UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A novel system for designing orthosis for muscloskeletal system
Title of the study (Brief title)	A novel system for designing orthosis
Region	Japan

Condition
Condition	Osteoarthritis of CM joint, Hallux Valugus, Flat foot
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To creat a novel system for designing orhtosis using CAD/CAM system
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Range of Motion, Past history, Type of surgery, Date of Surgery, VAS, Radiography, MRI
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with Osteoarthritis of CM joint, Halux Valgus and Flat foot. Healthy controls
Key exclusion criteria	Pregnant woman, unable to scan CT or superficial scan, age under 19 or over 71
Target sample size	200

Research contact person
Name of lead principal investigator	Takeo Nagura
Organization	Keio University, School of Medicine
Division name	Department of Orthopedic Surgery
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	03-5363-3812
Email	nagura@z8.keio.jp

Public contact
Name of contact person	Takeo Nagura
Organization	Keio University, School of Medicine
Division name	Department of Orthopedic Surgery
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	03-5363-3812
Homepage URL
Email	nagura@z8.keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Keio University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 01 Month 01 Day
Anticipated trial start date	2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Under revision of IRB

Management information
Registered date	2017 Year 12 Month 13 Day
Last modified on	2018 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034681